Biothera Announces Imprime PGG Positive Safety Findings And Pharmacokinetic Data From Two Phase 1 Studies, As Published In Investigational New Drugs: The Journal Of New Anticancer Agents

Imprime PGG (Beta 1,3/1,6 glucan) also has established proof of concept as an immuno-oncology therapy in subsequent single arm and randomized Phase 2 studies

With significant milestones anticipated throughout 2016, Biothera is advancing Imprime PGG towards registration trials by 2018

EAGAN, Minn.--(BUSINESS WIRE)--Biothera Pharmaceuticals Inc. today announced the peer-reviewed publication of positive safety and pharmacokinetic results from two randomized, double-blind, placebo-controlled Phase 1 clinical studies of Biothera’s lead candidate, Imprime PGG, in a total of 36 healthy volunteers. Imprime PGG is a first-in-class, systemically administered beta glucan PAMP (Pathogen Associated Molecular Patterning molecule). Imprime PGG acts as an immunological “ignition switch,” driving a coordinated innate and adaptive immune response to enhance the anti-tumor effects of checkpoint inhibitors (PD-1, PD-L1 antibodies), anti-angiogenic, and tumor-targeting monoclonal antibodies (mAbs).

According to the clinical trial findings published in Investigational New Drugs: The Journal of New Anticancer Agents (DOI 10.1007/s10637-016-0325-z), both single doses and repeated doses of Imprime PGG demonstrated a favorable safety profile and were well-tolerated. In the first Phase 1 study, subjects received a single intravenous infusion of placebo or Imprime PGG at doses of 0.5, 1.0, 2.0, 4.0 or 6.0 mg/kg. A second Phase 1 study was conducted in which volunteers received seven consecutive daily intravenous infusions or placebo or Imprime PGG at doses of 1.0, 2.0 or 4.0 mg/kg. In both studies, all observed adverse events were either mild or moderate in intensity, and no dose-limiting toxicities were observed. Pharmacokinetic findings showed that serum concentrations of Imprime PGG were linear with dose.

José Iglesias, M.D., Chief Medical Officer, Biothera Pharmaceuticals, stated, “We have consistently seen a favorable safety profile for Imprime PGG in healthy volunteers in Phase 1 and in subsequent studies in more than 400 subjects, including over 300 oncology patients. While other PAMPs must be injected directly into tumors, Imprime PGG has a unique mechanism of action and can be administered systemically, with the potential to target multiple cancer types and multiple tumor locations. Further, unlike bacterial and viral PAMPs, Imprime PGG does not target toll-like receptors (TLRs) nor the stimulator of IFN genes (STING), which reduces the risk of intolerable and potentially life-threatening cytokine storms. We are pleased with the publication of these results and look forward to the continued progress of our broad programs for Imprime PGG.”

Barry Labinger, Chief Executive Officer of Biothera Pharmaceuticals, said, “The safety, tolerability, and pharmacokinetic findings of these Phase 1 studies enabled a Phase 2 program which demonstrated proof of concept for Imprime PGG in multiple combinations and indications. We continue to build upon these data with translational research intended to optimize Imprime PGG combination regimens and validate a predictive biomarker to refine patient selection in future studies. We will initiate additional clinical trials this year, in combination with checkpoint inhibitors, which are intended to enable well designed registration trials beginning by 2018.”

About Biothera Pharmaceuticals Inc.
Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a first-in-class, mid-clinical stage cancer immunotherapy that orchestrates an integrated anti-cancer immune response in combination with checkpoint inhibitors and tumor-targeting and anti-angiogenesis monoclonal antibodies. Imprime PGG has been well-tolerated in trials in over 400 patients and has established proof of concept in multiple clinical studies, including single-arm and randomized phase 2 studies in non-small cell lung cancer (NSCLC), colorectal cancer, and chronic lymphocytic leukemia. More information is available at www.biothera.com or follow us on Twitter.